Canada Vigilance Adverse Reaction Monitoring Program and Database

Transcription

1 Canada Vigilance Adverse Reaction Monitoring Program and Database Network of Rare Blood Disorder Organizations Friday November 13, 2009 Heather Sutcliffe Director Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate Health Canada

2 Objective MedEffect TM Canada/Canada Vigilance Program and Database Data Management and Standards Privacy 2

3 Post-market surveillance is composed of three major activities: Information collection, processing and assessment Signal Detection and Evaluation Risk management (interventions) Adverse events occur and information is gathered. Reports are assessed for completeness and assigned medical terminology. Data entry into computer system. New risks are discovered with increased use of product in real world. Information is compiled from literature scan, other regulatory agencies, companies (PSURs, registries, clinical trials), etc. Many information sources combine to create a signal: a suspicion there is a connection between a product and reported adverse reactions. Evaluation consists in the scientific/medical review of multiple data sources to analyse risks and benefits, considering risk profiles of therapeutic alternatives. A risk management approach is defined which may include interventions such as: product recall, labelling changes, communicating risk information to health care professionals and the public. Interventions are normally communicated broadly as a mechanism to show accountability. 3

4 Canada Vigilance Program Spontaneous Adverse Reaction Reporting Program exists since 1965 Canada Vigilance Program (name change 2007) Mandatory reporting for Market Authorization Holders (i.e. manufacturers) Voluntary reporting for Health Professionals and Consumers Legislative Framework (e.g. Food and Drugs Act and Regulations (C ), Access to Information and Privacy Act etc.) 4

5 Purpose of Adverse Reaction Reporting Program Detection, prioritization, confirmation and risk management of signals SIGNAL reported information on a possible causal relationship between an adverse event and a health product the relationship being unknown or incompletely documented previously 5

6 Mandatory Reporting Market Authorization Holders (MAH) AR reports submitted by MAHs are collected by the Canada Vigilance National Office located in Ottawa MAHs are responsible as per the Food and Drug Regulations for the reporting of ARs to Health Canada Domestic AR report information is entered into the Canada Vigilance Database 6

7 Adverse Reaction Reports Domestic Adverse Reaction Reports Reports concerning reactions occurring in Canada to a product that is marketed in Canada Market Authorization Holder reporting within 15 calendar days of receiving the information (expedited reporting) Serious Adverse Reactions Unusual failure in efficacy reports for new drugs Foreign Adverse Reaction Reports Reports concerning reactions occurring outside Canada to a product with the same combination of active ingredients that is marketed in Canada Market Authorization Holder reporting within 15 calendar days of receiving the information (expedited reporting) Serious Unexpected Adverse Reactions 7

8 Canada Vigilance Regional Offices Collection of reports, review for completeness, follow-up with reporters Initial Data Entry into Canada Vigilance Workflow Provide acknowledgement letters to the reporters Increase health professional and consumer awareness of Canada Vigilance Provide guidance, in order to maximize the quality of reports Direct Canadians to Health Canada sources of new safety information Consumer Reporting Form/Guidelines Project for reporting of adverse reactions 8

9 Reporting to Canada Vigilance Adverse reaction reporting form Available Regional/National Offices, MedEffect website, CPS Submit by fax or mail On-Line submission Toll Free Telephone and Fax Verbal reports accepted Postage paid mail 9

10 Scope The Canada Vigilance Program collects adverse reaction reports for the following marketed health products approved for use in humans: Pharmaceutical drugs (prescription and non-prescription) Biologics (Schedule D, biotechnology products, therapeutic and diagnostic vaccines and fractionated blood products) Radiopharmaceuticals drugs Natural health products Cells, Tissues and Organs (CTOs) 10

11 Thousands Canada Vigilance Program Domestic Reports No. of domestic reports received Reports 20,360 Domestic Reports Received in

12 Thousands Canada Vigilance Program Foreign Reports No. of foreign reports received Reports 241,417 Foreign Reports Received in

13 Source of Domestic Reports ** * * Community Consumer, patient and non-hospital based health care professionals ** MAH Market Authorization Holder (MAH) 13

14 Reporter Type Domestic Reports

15 Serious Domestic Reports

16 Product Type Domestic Reports

17 Reporting Method Domestic Reports

18 Adverse Reaction Data Each report represents the suspicion, opinion or observation of the individual reporter Cause and effect relationships have not been established in the vast majority of reports submitted Only a small proportion of suspected adverse reactions are reported to the program, consequently this information must not be used to estimate the incidence of adverse reactions 18

19 MedEffect TM Canada Initiative Launched in August 2005 to better communicate health product safety information and increase awareness of AR reporting Centralized access to : Reliable & relevant health product safety information Advisories & CARN Information on how to report ARs & other reporting initiatives Industry Guidance & Templates for Issuance of Health Professional & Public Communications 19

20 MedDRA Terminology Medical Dictionary for Regulatory Activities MedDRA Implemented with Canada Vigilance Standardized terminology for classification, retrieval, presentation and communication of medical information (ICH standard) Scope: symptoms, signs, diseases and diagnoses, investigations and tests, therapeutic indications, surgical and medical procedures, & medical, social and family history Includes medication error related terms Sharing of data requires consistency of data coding and assessment Facilitates standardized electronic transmission of medical information Terminology and MedDRA training provided free of charge to academic researchers 20

21 Canada Vigilance Online Reporting Form The Canada Vigilance Adverse Reaction (AR) Monitoring Program offers health professionals and the public the ability to complete and submit an AR report online through the MedEffect Canada website. 21

22 Canada Vigilance Online Database This database is available on the MedEffect Canada website and enables users to query AR report-related information extracted from the Canada Vigilance AR database. This site will be undergoing a re-design to improve the search capabilities. 22

23 Canada Vigilance Database Health Products & Food Branch Common Database 23

24 Data Management and Standards Data Management and Standards are important to Adverse Reaction Reporting and Assessment International Sharing of data between Regulatory Agencies requires consistency of data coding and assessment ICH (International Conference on Harmonization) HL7 (Health Level Seven) Other organizations: WHO International Drug Monitoring Program and CIOMS (Council for International Organizations of Medical Sciences) 24

25 Canada Vigilance: Privacy Access to Information and Privacy Acts Privacy Impact Assessment Threat Risk Assessment 25

26 Privacy Principles Accountability for Personal Information Collection of Personal Information Consent Use of personal Information Disclosure and Disposition of Personal Information 26

27 Privacy Principles Accuracy of Personal Information Safeguarding Personal Information Openness Individual s Access to Personal Information Challenging Compliance 27

28 Registries Tool used in surveillance of patients and products Require development in accordance with privacy act Established by a variety of organizations (Manufacturers, CIHI) Examples of registries: Clozapine (manufacturer), Hip Implants (CIHI) Health Canada does not establish or fund registries Progressive Licensing Project will include regulatory requirements for post-market commitments depending on the information available in the pre-market phase which could include a registry 28

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30 Background Information 30

31 Monitoring Inputs Integrating Multiple Sources Environmental Scanning: Media Medical Literature Regulatory Agencies: Reporting databases Risk Communications Companies: Phase IV Studies PSURs Registries Health Canada: Canada Vigilance Program WHO Vigimed Signal Detection Capacity Signal Detection / Selection RISK COMMUNICATIONS Label changes Public Advisory Health Professional Letter Notice to Hospitals Press Release Can Adv Reaction Newsletter Listserv MedEffect e-notice Signal Assessment Capacity Signal Assessment Risk Mitigation Strategies Developed Risk Management Capacity 31

32 Canada Vigilance Database: Business Requirements Clinical trial AR requirements Post market AR requirements Signal Detection & powerful query tools ICH compliant (E2B, MedDRA, ESTRI-Gateway) Management & ICSR reporting Scanning and Imaging Capability for future integration document management solution, small manufacturer reporting interface 32

33 Canada Vigilance Database The Canada Vigilance database is comprised of an integrated and complementary suite of 3 applications which include: Core application Signal detection tool ESTRI gateway module 33

34 Canada Vigilance Database: Core Application For the collection, coding, assessment and reporting of adverse reaction data Workflow module routes AR cases to Specialists/Assessors automatically, based on pre-defined criteria such as drug class, seriousness, etc. Enables full compliance with the ICH international AR reporting requirements, such as ICH E2B, MedDRA coding, etc. Configurable and will offer English and French user interfaces Scanned images of AR reports 34

35 Canada Vigilance Database: Signal Detection Data mining and signal detection tool Facilitates safety data analysis Facilitates the identification of patterns in the data and identify possible associations underlying signals Users can build, save and share ad-hoc queries Provides access to the FDA (FOI) data, a larger pool of data for analysis and signal detection Statistical module includes algorithmic analyses, such as PRR, Bayesian, Chi-Square, Log-Likelihood 35

36 Signal Detection: Standard Reports 36

37 Signal Detection: Analysis Tool 37

38 Signal Detection: Statistical Analysis 38

39 Signal Detection: Trend Analysis 39

40 Canada Vigilance Database: Trend Analysis Outputs 40

41 Canada Vigilance Database: Electronic Exchange ESTRI Gateway module Enables the secure electronic exchange and management of safety information in the ICH E2B and M2 standards Planned implementation for Phase 2 of this project 41

42 Canada Vigilance Database Sub-Projects Post-Market Implementation (MHPD) Sustainability and On-Going Maintenance Post-Market On-Line Database Clinical Trials Implementation (BGTD, NHPD, TPD) Electronic Reporting by Small/Medium/Large MAH/Sponsors Signal detection business transformation project underway 42

43 Electronic Reporting by Small/Medium/Large MAHs/Sponsors Project Concept Requirements Project Charter Options Analysis Acquisition Cycle Development/ Construction Testing/QA Pilot(s) & Implementation Progressive Implementation 43

44 Proposed Timeline Acquisition Cycle Fall 2009 Electronic Reporting Pilots starting Fall 2010 Staggered implementation by small/medium/large MAHs 44

45 Questions? 45